DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The Information Disclosure Statements filed on 10/4/2024 have been entered and considered. Initialed copies of the form PTO-1449 are enclosed with this action.
Status of claims
Claims 1-27 are pending and examined in the office action.
Priority
Instant application, filed 7/1/2024, does not have priority applications.
Claim Rejections - 35 USC § 112
Enablement/Deposit
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-27 are rejected under 35 U.S.C. 112(a), as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims are drawn to a pepper plant comprising at least a first set of the chromosomes of pepper line SBO-XZ20-0212 (one particular example is DRPB3992), a sample of seed of said line having been deposited under NCMA Accession No. 202404029, a seed producing the plant, plant part, tissue culture, method of using the plant, and more.
The pepper line SBO-XZ20-0212 and hybrid DRPB3992 appear to be novel biological materials. Since the seeds claimed are essential to the claimed invention, they must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If a seed is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112. The specification does not disclose a repeatable process to obtain the exact same seed in each occurrence and it is not apparent if such a seed is readily available to the public.
The examiner noticed that in the specification ([0093]): “deposit of at least 625 seeds of pepper line SBO-XZ20-0212 and pepper SBO-XZ15-0097, disclosed above and recited in the claims, has been made with the Provasoli-Guillard National Center for Marine Algae and Microbiota (NCMA), 60 Bigelow Drive, East Boothbay, Maine 04544, USA and the American Type Culture Collection (ATCC), 10801 University Blvd., Manassas, VA 20110-2209, respectively. The dates of deposit for those deposited seeds of pepper line SBO-XZ20-0212 and pepper line SBO-XZ15-0097 are April 23, 2024 and March 26, 2018, respectively. The accession numbers for those deposited seeds of pepper line SBO-XZ20-0212 and pepper line SBOXZ15-0097 are NCMA Accession No. 202404029 and ATCC Accession No. PTA-125001, respectively. Upon issuance of a patent, all restrictions upon the deposits will be removed, and the deposits are intended to meet all of the requirements of 37 C.F.R. §§ 1.801-1.809. The deposits have been accepted under the Budapest Treaty and will be maintained in the depositary for a period of 30 years, 5 years after the last request, or the effective life of the patent, whichever is longer, and will be replaced if necessary during that period.”
However, according to MPEP 2404.01, “The mere reference to a deposit or the biological material itself in any document or publication does not necessarily mean that the deposited biological material is readily available. Even a deposit made under the Budapest Treaty and referenced in a United States or foreign patent document would not necessarily meet the test for known and readily available unless the deposit was made under conditions that are consistent with those specified in these rules, including the provision that requires, with one possible exception (37 CFR 1.808(b)), that all restrictions on the accessibility be irrevocably removed by the applicant upon the granting of the patent. Ex parte Hildebrand, 15 USPQ2d 1662 (Bd. Pat. App. & Int. 1990)”.
In this case, the statement of “all restrictions on the accessibility be irrevocably removed” is missing in the specification. Without such statement, the deposit does not meet the requirement.
A statement by an attorney of record over his or her signature and registration number, stating that the seeds will be irrevocably and without restriction or condition released to the public upon the issuance of a patent would address the issue raised herein.
In addition, there is no deposit receipt or any document from NCMA filed by the applicant.
Lacking written description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 10, 14, 16-18 are rejected under 35 U.S.C. 112(a), as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
To claim a genus under the written description requirement, the applicant is required to describe a representative number of species to reflect the variation within the genus or structures sufficient to define the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combinations thereof.
By court' s statement in Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), a written description of an invention “requires a precise definition, such as a structure, formula, or chemical name, of the claimed subject matter sufficient to distinguish it from other materials”; further, a written description of a claimed genus requires a description of a representative number of species of the claimed genus, and one of skill in the art should be able to “visualize or recognize the identity of the members of the genus”.
Regarding claim 10, the claim is broadly drawn to a genus of pepper plants having all of the physiological and morphological characteristics of the pepper plant of claim 1.
By BRI, the claim is interpreted as to a genus of pepper plants having all the physiological and morphological characteristics of any plant in the genus of pepper plants of claim 1 (having a first set of the chromosome of SBO-XZ20-0212, the second set of the chromosome is not specific, and is a genus of chromosomes). In another word, by BRI, the physiological and morphological characteristics is not of one (or two) particular species, is of any species of the genus.
According to the specification ([0027]), the parents of pepper hybrid DRPB3992 are pepper line SBO-XZ20-0212 and pepper line SBO-XZ15-0097. Accordingly, SBO-XZ20-0212 is one of the two parents of hybrid DRPB3992; and hybrid DRPB3992 is the only described species of F1 progeny of SBO-XZ20-0212 (the second parent is specific SBO-XZ15-0097).
The specification only describes representative physiological and morphological characteristics of DRPB3992 and SBO-XZ20-0212 (Table 1 in p9-11).
The specification does not describe physiological and morphological characteristics of the genus of pepper plants having all the physiological and morphological characteristics of the plant of claim 1. the specification does not describe physiological and morphological characteristics of any species other than of SBO-XZ20-0212 or of DRPB3992.
Please note that DRPB3992 (F1 progeny) has different physiological and morphological characteristics from that of SBO-XZ20-0212 (parent). For example, DRPB3992 has long stem, while SBO-XZ20-0212 has a medium stem; for another example, DRPB3992 has a moderately convex in leaf profile, while SBO-XZ20-0212 has a flat leaf profile (Table 1 in p9-11).
In the art, one set of chromosomes does not fully determine the physiological and morphological characteristics of any organism. Trait genes can be dominant or recessive. For example, Foolad (Genome Mapping and Molecular Breeding of Pepper. International Journal of Plant Genomics, p1-52, 2007) teaches that cultivated peppers have dominant and recessive genes (p7, left col, 1st para to right col, 1st para; p18, left col, 2nd para; p31, right col, 1st para; p33, right col, 1st para). Foolad also teach that the genetic structures are diversified within the cultivated species (p11, left col, last para), and that in F1 hybrids, there are excessive variations including undesirable variations in traits/physiological and morphological characteristics (p14, right col, 1st para).
Hence, in the instant case, the second set of chromosomes is generic not specific, and the genes can be very different among the species. Hence, the pepper plants of claim 1 are heterologous in genetic structure; and hence, the physiological and morphological characteristics of the genus of plants are also heterologous (each species is different). Not only the 2 species SBO-XZ20-0212 and DRPB3992 have different physiological and morphological characteristics, but also neither one of them describe the common genetic structure of the claimed genus of pepper plants (having only one set of chromosomes of SBO-XZ20-0212) and the associated physiological and morphological characteristics.
According to Vas-Cath Inc. v. Mahurkar 1991 (CA FC) 19 USPQ2d 1111, 1115, which teaches that the purpose of the written description is for the purpose of warning an innocent purchaser, or other person using a machine, of his infringement of the patent; and at the same time, of taking from the inventor the means of practicing upon the credulity or the fears of other persons, by pretending that his invention is more than what it really is, or different from its ostensible objects, that the patentee is required to distinguish his invention in his specification. In this case, there is no way that a practitioner would be able to determine if any particular maize plant is infringing the instant claims, and therefore, the public has not been put on notice with a sufficient description of the claimed invention. (See Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004)).
Regarding claim 14, the claim is broadly drawn to a genus of pepper plants produced by the method of claim 13.
Claim 13 recites a method comprising:
(a) utilizing as a recurrent parent the plant of claim 1 by crossing said plant with a donor pepper plant that comprises a trait to produce F1 progeny;
(b) selecting an F1 progeny that comprises the trait;
(c) backcrossing the selected F1 progeny with a plant of the same pepper line used as the recurrent parent in step (a) to produce a backcross progeny;
(d) selecting a backcross progeny comprising the trait and otherwise comprising the morphological and physiological characteristics of the recurrent parent pepper line used in step (a); and
(e) repeating steps (c) and (d) three or more times to produce a selected fourth or higher backcross progeny.
According to the specification ([0027]), the parents of pepper hybrid DRPB3992 are pepper line SBO-XZ20-0212 and pepper line SBO-XZ15-0097 (another specific parent).
Thus, DRPB3992 is a specific species of the F1 progeny of the genus of pepper line SBO-XZ20-0212. Therefore, “the plant of claim 1” recited in claim 13 are or encompass F1 progenies of SBO-XZ20-0212.
Accordingly, the “F1 progeny” recited in claim in step (a) of claim 13 is actually F2 progeny regarding SBO-XZ20-0212 (of claim 1). Steps (c) to (e) produces progenies beyond F2 generation.
Thus, a genus of pepper plants produced by the method of claim 13 recited in claim 14, are or encompass progenies of SBO-XZ20-0212 of F2 generation and beyond.
The specification does not describe any F2 progeny of SBO-XZ20-0212, inbred, or hybrid, the physiological and morphological characteristics thereof, not to mention the common structure feature of F2 progenies and beyond. The specification does not describe a single species of F2 progeny of SBO-XZ20-0212. In fact, DRPB3992 is the only described F1 progeny of SBO-XZ20-0212 by the specification.
In addition, in the art, Foolad further teaches that from generation to generation of backcrossing of peppers, the genetic constitution changes, and the traits/physiological and morphological characteristics are instable in F2 and F3 generations (p14, right col, 1st to 2nd para).
Accordingly, the plants beyond F1 do not retain at least a full half set of chromosomes from the original plant. The claims read on higher filial generation seeds, plants and parts that have any number of genomic, phenotypic and morphological changes in comparison to the variety SBO-XZ20-0212. The different plants have can have different genomic, phenotypic and morphological characteristics, including different transgenes. In addition, the genus of seeds, plants and parts may loss the structural, physiological and morphological characteristics of seed and plant of the variety by generations of crossing.
Thus, the genus of pepper plants recited in claim 14 are further off from SBO-XZ20-0212 in structure and function.
Regarding claims 16-18
According to the specification ([0023]), When used in conjunction with the word "comprising" or other open language in the claims, the words "a" and "an" denote "one or more," unless specifically noted otherwise.
Claim 16 recites a pepper plant produced by the method of claim 15. Claim 15 recites a method comprising introducing a (not “a single” like in claim 20) transgene conferring the trait into the plant of claim 1. Claim 17 recites a pepper plant comprising at least a first set of the chromosomes of pepper line SBO-XZ20-0212 further comprising a (not “a single” like in claim 20) transgene.
Accordingly, claims 16-18 are broadly drawn to a genus of pepper plants comprising at least a first set of the chromosomes of pepper line SBO-XZ20-0212, and further comprising a genus of transgenes.
The specification only describes SBO-XZ20-0212 and DRPB3992, neither of them further comprises any transgene.
The specification does not describe any pepper plant comprising at least a first set of the chromosomes of pepper line SBO-XZ20-0212 further comprising a transgene, not to mention the common structure feature of the genus of plants comprising a genus of transgenes.
In the art, Ladics et al (Genetic basis and detection of unintended effects in genetically modified crop plants. Transgenic Res 24:587–603, 2015) teach that insertion of transgenes can contribute to unintended effect in crop plants (p589, right col, last para; p590, left col, 1st para). Ladics et al teach that it is hard to predict whether pleiotropy (a single gene influences multiple traits) is likely to occur. For example, it is observed that lack of anthocyanin production in transgenic pepper comprising a heterologous gene regulating flavonol and anthocyanin production--the pepper plants had increases in some flavonols but no anthocyanin production because pepper lacks sufficient expression of another gene required for anthocyanin production. Variation in regulatory mechanisms is not only observed at the species level—different genotypes of the same species can have variation in regulatory mechanisms, which is one reason there is so much phenotypic and phenologic diversity in crop species. (p590, right col, last para; 591, left col, 1st para).
Given that the transgenes are not specific but generic, the claimed genus does not have any common structure and are heterologous in structure, physiological, and morphological characteristics.
Regarding the aspect of representative number of species, SBO-XZ20-0212 and the DRPB3992 are the only 2 species described by the specification that comprise one set of chromosomes of SBO-XZ20-0212, and neither one further comprises any transgene.
The specification does not describe any species of F2 progeny nor any species further comprising any transgene(s).
Given that claim 8 does not have any requirement for genetic structure, the claimed plants having all the physiological and morphological characteristics of the plant of claim 1 is a heterologous genus of pepper plants, the number of species is extremely large, and are heterologous in structure.
The inbred and hybrid progenies of F2 generation and beyond of SBO-XZ20-0212 (claim 12) are an extremely large number, and are heterologous in structure.
Given the transgenes are generic not specific, the transgenic pepper plants (claims 14-16) are an extremely large number, and are heterologous in structure.
Hence, SBO-XZ20-0212 or DRPB3992 does not describe the common structure feature of the genera of pepper plants, and does not represent (not to mention sufficiently represent) the genus of the pepper plants as broadly claimed.
Therefore, the application has not met either of the two elements of the written description requirement as set forth in the court' s decision in Eli Lilly, and has not shown her/his possession of the claimed genera.
Remarks
According to the specification ([0027]), the parents of pepper hybrid DRPB3992 are pepper line SBO-XZ20-0212 and pepper line SBO-XZ15-0097. The parent lines are uniform and stable, as is a hybrid produced therefrom.
DRPB3992, by name search, does not have prior art in patents or NPLs. DRPB3992 and the traits thereof were disclosed by Bayer (PDF attached, no evidence it was before or on 7/1/2024, instant filing date).
SBO-XZ20-0212, by name search, does not have prior art in patents or NPLs.
Prior art does not teach any pepper plant having all of the physiological and morphological characteristics, and genetic background, of SBO-XZ20-0212 or DRPB3992.
SBO-XZ15-0097 (not instantly claimed), was disclosed and claimed in US Patent 10582692 (granted and published 3/10/2020, filed by Seminis 5/8/2018). See claim 1 and Abstract of the US Patent.
The combination of SBO-XZ20-0212 and SBO-XZ15-0097 does not have prior art in patents or NPLs.
Claims 25-27 are not rejected under 35 USC 101 because SBO-XZ20-0212 is deemed as a novel cultivar. Thus, determining the genotype of the plant of claim 1 is not taught and cannot be deemed as routine.
The closest prior art:
Stoll (US Patent 10582692, granted and published 3/10/2020, filed by Sminis 5/8/2018). Stoll discloses and claims plant and seed of pepper hybrid SBO-XZ15-0097 (reference pepper) and pepper plants comprising at least a first set of the chromosomes of SBO-XZ15-0097 (Abstract, claims 1-5).
Reference pepper shares some representative physiological and morphological characteristics of instant SVPB8161 or SBO-XZ20-0212, and differs in some (Reference Table 1 in col 6-10, instant specification Table 1 in p9-11). Reference pepper only shares one parent SBO-XZ15-0097 with instant DRPB3992 (not instant SBO-XZ20-0212) (Reference col 6, lines 1-10; instant specification, [0027]), thus, reference and instant peppers also have different parents/genetic backgrounds.
Conclusion
No claim is allowed.
Contact information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WAYNE ZHONG whose telephone number is (571)270-0311. The examiner can normally be reached 8:30am to 5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bratislav Stankovic, can be reached on 571-270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Wayne Zhong/
Primary Examiner, Art Unit 1662